Multicenter evaluation of MRI-targeted prostate biopsy
Recruiting
- Conditions
- C61R77.80Malignant neoplasm of prostate
- Registration Number
- DRKS00005986
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 509
Inclusion Criteria
1. Men referred for an initial prostate biopsy;
2. PSA > 3.0 and <50 ng/ml;
3. No contraindications to mp-MRI.
Exclusion Criteria
1. Prior prostate biopsy;
2. Highly suspicious prostate nodule on DRE;
3. Contraindications to prostate biopsy;
4. Known prostate cancer.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of men diagnosed with significant cancers defined by Gleason score =7 disease by the two methods (MRI-targeted biopsies vs. standard biopsies).
- Secondary Outcome Measures
Name Time Method 1. Proportion of men diagnosed with clinically insignificant prostate cancer (MRI-targeted biopsies vs. standard biopsies).<br>2. Proportion of men diagnosed with significant cancers defined by Gleason score =7 disease in MRI-targeted biopsies in men with PI-RADS sum =9 vs. the rest.<br>3. Overall cancer detection rates of MRI-targeted biopsies vs. MRI-targeted biospies in combination with standard biopsies.<br>4. Proportion of positive cores with any cancer (number of cores with cancer / number of cores taken).<br>5. Proportion of positive cores with clinically important cancer (number of cores with cancer / number of cores taken).<br>6. Number of cases where MRI shows definitive lesions but biopsy shows no cancer or Gleason score 6 cancer (false positive rate).<br>7. Location and size of tumors detected by either sampling strategy or both.<br>